Device product
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Z-1391-2022
Product summary
- Event
- Event 90484
- Status
- Completed
- Classification
- Class II
- Quantity
- 67
- Official record key
device-enforcement:Z-1391-2022
Official wording
Reason: Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Code information: UDI-DI (GTIN): 04046963419639
Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
Derived failure modes
-
Unknown
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.